The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa

The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa



Sponsors


Source

University of Cape Town

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in
which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a
colourful, translucent bar of soap with a toy embedded in its centre.

Overall Status

Completed

Start Date

2014-09-01

Completion Date

2015-12-15

Primary Completion Date

2014-12-15

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Direct observation of hand washing prior to eating a snack
8 weeks

Secondary Outcome

Measure

Time Frame

Questionnaire data on hand washing after using the toilet (scale of 1-10)
8 weeks
Questionnaire data on hand washing prior to meals (scale of 1-10)
8 weeks
Questionnaire data on general soap usage when washing hands (scale of 1-10)
8 weeks
Questionnaire data on experience of illness (13 items)
2 weeks

Enrollment

288

Conditions


Intervention

Intervention Type

Combination Product

Intervention Name


Description

HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.

Arm Group Label

Hope Soap group


Intervention Type

Combination Product

Intervention Name


Description

A colourful, translucent bar or soap with the toy alongside it

Arm Group Label

Control group



Eligibility

Criteria

Inclusion Criteria:

- Enrolled in the Family-in-Focus program

- Caregiver provided informed consent

- the age-eligible children were not involved in any other sort of ECD program (e.g.
crèche or other day-care)

Exclusion Criteria:

- Enrollment in an ECD program

Gender

All

Minimum Age

3 Years

Maximum Age

9 Years

Healthy Volunteers

No


Verification Date

2017-09-01

Lastchanged Date

2017-09-12

Firstreceived Date

2017-09-08

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Cape Town

Investigator Full Name

Brendan Maughan-Brown

Investigator Title

Senior Research Officer


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Hope Soap group

Arm Group Type

Experimental

Description

Children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre


Arm Group Label

Control group

Arm Group Type

Active Comparator

Description

Children in control households received a colourful, translucent bar or soap with the toy alongside it.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

None (Open Label)



ClinicalTrials.gov processed this data on September 13, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2017 ICH GCP